Additional Relevant Details
The single and multiple ascending dose trial enrolled a total of 77 healthy volunteers. The pharmacokinetic measurements showed increased exposure with increasing doses. The half-life of CTP-543 was approximately 3.3 hours, similar to that reported for non-deuterated ruxolitinib1. CTP-543 was well-tolerated across all dose groups and there were no serious adverse events reported in subjects who received CTP-543.The safety and exposure observed with 16 mg of CTP-543 twice daily appeared comparable to the reported exposure of 20 mg ruxolitinib twice daily. Published findings from an open-label clinical trial of 12 patients with alopecia areata conducted by investigators at Columbia University demonstrated that 20 mg of ruxolitinib administered twice daily resulted in significant hair regrowth in 75% of patients with moderate to severe alopecia areata2.